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Completed

NCT Number: NCT00125047

Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aga Khan University

Karachi, Pakistan

About this study

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence; is given as a single dose; lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.

Secondary objectives of this trial are:

  • To monitor the adverse events following a routine Vi mass vaccination campaign;
  • To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
  • To study typhoid fever risk factors in the population.

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Registered in the project census
  • Age: 2-16 years

Exclusion criteria

  • Fever >37.5 degrees Celsius, axillary
  • Pregnancy
  • Lactating

Treatment and study plan

Typhoid Vi vaccine

Biological

Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.

Other names: Typherix

Hepatitis A Vaccine

Biological

single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen

Other names: Havrix

Primary outcomes

  1. Total protection against S. typhi

    Time frame: 2 years from zero time

Secondary outcomes

  1. Indirect protection against s. typhi

    Time frame: two years from zero time

  2. Overall protection against s. typhi

    Time frame: 2 years from zero time

  3. Adverse event(s) following immunization

    Time frame: 30 days from vaccination

Sponsors and collaborators

Lead sponsor

International Vaccine Institute

Other

Collaborators

  • Aga Khan University
  • GlaxoSmithKline
  • University of Western Ontario, Canada
  • Wellcome Trust

Registry information

Official study title

Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jul 29, 2005
Registry last updated
Aug 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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